Sr Manager, Formulation Development

Job Summary

We are looking for a dynamic, change-inspired product development Sr. Manager to execute RD product development projects, managing external CDMO/CMO, and managing the RD bench scientists.

The role holder will lead the product development, review technical data, prepare and review technical documents, co-ordinate with CDMOs and CMOs for smooth technology transfer of projects. This role aligns closely with evolving RD needs, leveraging a strong working knowledge of pharmaceutical RD workflows, data and applicable concepts to effectively coordinate with external vendors and internal stake holders.

Key Responsibilities

• Oversee all formulation activities required for supporting product development in RD and/or CRO and/or CMO and/or CDMO.
• Review of data generated in RD lab ensuring maintenance of data quality throughout product development and lifecycle.
• To supervise and monitor the technical development front and provide timely and accurate inputs necessary on various aspects of the ongoing programs.
• Drafting and/or review of specifications, product development reports, technology transfer protocol and reports prepared by RD and/or CRO and/or CMO and/or CDMO.
• Review of various trials, pilot, pivotal, confirmation, submission batch documents, e.g., batch manufacturing records, process validation protocols and reports, etc.
• Draft and/or review of various CMC study protocols and reports, e.g., ICH stability study, photo-stability study, hold time study, in-use study, thermal excursion studies, and technical summary report, etc.
• Understand the different product development and tech transfer strategies in consultation with the regulatory and intellectual property requirement.
• To monitor the execution of scale-up batches and submission batches at CMO s and to present for the batch s execution at CMO s if required.
• To supervise the outsourcing in co-ordination with the CFT members.
• Identify the need for regulatory license requirement for manufacturing, testing import and timely communicate such requirements to the concerned CFTs.
• Identify project needs such as equipment, instruments, manpower and escalate for their approvals.
• Carry out timely communication plan with partners and follow up for timely and accurate delivery.
• Conduct the stage gate meeting and internal review with cross functional teams to update all the key stake holders.
• Ensure documentation compliance according to quality and regulatory requirements.
• Ensure compliance to quality and other policies/systems laid down by organization.
• Responding to all the product development queries deficiencies arising from the regulatory agencies.
• Ensure the relevant self-training in line with the organizational policies.

Preferred Qualifications

• Pharm or Ph.D in Pharmacy with minimum industrial experience of 12 years in product development and scale-up of products.
• Preferred areas of expertise are IR/ER Oral Solid and Liquid Dosage forms, hands on technologies like HME, nanoparticulate, Wurster process, etc.
• Good understanding of PK/BA/BE.
• Global Product Development Experience is preferred while core area should be US.
• Experience of developing branded and differentiated products - 505(b)(2) category would be preferred.
• Experience of working with CROs/CDMOs would be preferred.
• Support the Quality management system (QMS) documents such as change controls, deviations, out of specifications etc.
• Facilitate completion of required training for self and the team.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.